EMBOZENE MICROSPHERES
Device, Vascular, For Promoting Embolization
CELONOVA BIOSCIENCES, INC.
The following data is part of a premarket notification filed by Celonova Biosciences, Inc. with the FDA for Embozene Microspheres.
Pre-market Notification Details
| Device ID | K132675 |
| 510k Number | K132675 |
| Device Name: | EMBOZENE MICROSPHERES |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | CELONOVA BIOSCIENCES, INC. 18615 Tuscany Stone Ste 100 San Antonio, TX 78258 |
| Contact | Nicole Barber |
| Correspondent | Nicole Barber CELONOVA BIOSCIENCES, INC. 18615 Tuscany Stone Ste 100 San Antonio, TX 78258 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-28 |
| Decision Date | 2013-10-03 |
| Summary: | summary |
Trademark Results [EMBOZENE MICROSPHERES]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EMBOZENE MICROSPHERES 86268331 4684062 Live/Registered |
BOSTON SCIENTIFIC LIMITED 2014-05-01 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.